The FDA issued a Form 483 to Noven Pharmaceuticals after observing numerous problems at the transdermal drug manufacturer’s Miami, Florida facility.
The agency found the process qualification protocol used with the firm’s transdermal product, Minivelle, did not include complete data to support time-dependent manufacturing activities. For certain samples, it lacked information required to justify their statistical significance.
The facility’s quality standards program for evaluating quality attributes during in-process inspection failed to include examples of all potential critical or major defects necessary for a consistent and full inspection. Critical defects for un-pouched units, such as missing or incomplete adhesive, are not described in any record at the facility.
In addition, one of the company’s cleaning validation protocols for its Minivelle coating operation did not describe actions taken to ensure consistency in cleaning activities for stainless steel kettles used in manufacturing. For example, the protocol did not include a clear labeling of sampling points selected to ensure the hardest to clean locations were sampled during the exercise.
Another SOP approved for use in describing general cleaning activities of all production areas lacked complete and accurate documentation of activities. In addition, cleaning activities did not have documentation showing all steps were performed as required.
The firm’s retention sample program also had no description of steps for visual inspection to evaluate product conformance to specifications.